Using fluconazole to enhance treatment response in Crohn's disease
A Prospective, Randomized, Placebo-controlled Trial of Fluconazole in Combination With IL-23 Therapy Versus IL-23 Therapy Alone for the Treatment of Crohn's Disease
This study is testing if adding fluconazole to IL-23 treatments can help people with Crohn's disease feel better.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Drugs / interventions | ustekinumab, risankizumab, guselkumab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06274554 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of fluconazole on the efficacy of IL-23 therapies in patients with Crohn's disease. Participants will be randomized into two groups: one receiving IL-23 therapy with fluconazole and the other receiving IL-23 therapy with a placebo. The study will assess patient responses through standard care visits and collect stool and blood samples at various intervals. The goal is to determine if fluconazole improves the response to IL-23 therapies when administered concurrently.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with mild to moderate Crohn's disease who are stable on their current medications.
Not a fit: Patients with recent antibiotic or antifungal use, known allergies to fluconazole, or significant liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with Crohn's disease.
How similar studies have performed: While the combination of fluconazole with IL-23 therapies is a novel approach, similar studies have shown promise in enhancing treatment responses in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients at least 18 years old 2. Patients with mild to moderate Crohn's disease as defined by CDAI score of 150-450 Exclusion Criteria: 1. Antifungal usage within one month prior to initiation of blinded fluconazole usage 2. Known allergy to fluconazole 3. Patients with known hepatic disease, cirrhosis, or with elevated liver biochemistries (e.g., transaminase(s) \>3X upper limit of normal (ULN), and/or bilirubin levels \>1.5X ULN (with exception of confirmed Gilbert's disease) at baseline 4. Patients taking any medications judged by clinical provider to interact with fluconazole and are known contraindications (refer to section 2.2) and cause serious adverse events, including but not limited to death, cardiac events, serious cardiac dysrhythmias, and prolongation of QTc 5. Pregnant or lactating women 6. Severe Crohn's disease defined by a PRO-2 score ≥ 34 or imminent need for surgery, or deemed not medically fit by physician 7. Patient with symptomatic stricturing 8. Patient with pouchitis or an ostomy 9. Patients with known, active fungal infection(s) since these patients would require particular, standard-of-care monitoring and treatment, which may include intravenous and/or prolonged courses of fluconazole or other therapies. 10. Patients with hypokalemia, or advanced cardiac failure 11. Patients with renal insufficiency
Where this trial is running
New York, New York
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Randy Longman, MD, PhD — Weill Medical College of Cornell University
- Study coordinator: Caroline Ericsson, BS
- Email: cae4007@med.cornell.edu
- Phone: 646-697-0985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.